CTM Product definition

CTM Product means Compound together with any formulation ingredients in a finished pharmaceutical dosage form suitable for administration and dosing to humans in clinical trials, but not in suitable form for commercial sale (for example, without limitation, not in packaged form such as blister packs or other containers and not including external packaging and package inserts).

Examples of CTM Product in a sentence

  • PII will notify RBX in writing upon Completion of the [*] in any country in the Territory to be performed in the Development Plan involving a CTM Product within fourteen (14) days of such Completion.

  • GenuPro shall in good faith and at no charge to Licensee promptly following the Effective Date, but in any event within ten (10) days of the Effective Date if this Agreement, transfer to Licensee all GenuPro Compound and CTM Product in its possession as of the Effective Date of this Agreement.

  • Licensee will notify GenuPro in writing upon its first initiation of a Phase III Clinical Study in the Field involving a CTM Product within fourteen (14) days of such initiation.

  • Upon request by Licensee, GenuPro shall take reasonable steps to assist Licensee to identify and qualify a Third Party contractor for the supply of quantities of Compound or CTM Product to Licensee and direct services by such Third Party contractor.

  • Licensee shall at its own expense provide all quantities of Compound, CTM Product and Licensed Product that Licensee needs in order to develop, commercialize and market Licensed Product in the Field in the Territory.

  • PII shall be solely responsible for (i) the manufacture of CTM Product and Drug Substance as may be required to obtain Regulatory Approval of the Licensed Product(s) in the Territory and (ii) the manufacture of commercial requirements of the Licensed Product(s) for marketing and sale in the Territory.

  • PII will notify RBX in writing upon the Completion of the [*] in any country of the Territory to be performed in the Development Plan involving CTM Product within fourteen (14) days of such Completion.

  • Licensor shall in good faith and at no charge to Licensee promptly following the Option Exercise Date, but in any event within ten (10) days of the Option Exercise Date, transfer to Licensee all CT Compounds and CTM Product in its possession as of the Option Exercise Date of this Agreement.

  • QS Pharma shall perform: Analytical method transfer, development and/or qualification for API, Product & Placebo Formulation development and feasibility batch manufacture of Product CTM Product and Placebo manufacture and packaging Stability testing of Product and CTM Product and Placebo Analytical methods will be transferred and/or modified to support the CTM manufacture.

Related to CTM Product

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

  • 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.

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

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

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

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • 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;

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

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

  • 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.

  • 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.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Licensed Compound means [***].

  • 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.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • 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.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • 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.”

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

  • 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.

  • 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.”

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.