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).
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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.

  • 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.

  • 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 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 any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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;

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

  • 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.

  • 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.

  • Licensed Compound means [***].

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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—

  • 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;

  • 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.

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