Bulk Licensed Product definition

Bulk Licensed Product means the Licensed Product in final dosage form using Xxxxxx Xxxxx’x formulation or any Cypress Formulation and “Finished Licensed Product” shall mean the Licensed Product in final dosage form including primary and secondary packaging and ready for use by the ultimate consumer.
Bulk Licensed Product means finished capsules of the Licensed Product to be used in clinical trials packaged in bulk.
Bulk Licensed Product means TGC's CFTR gene therapy product, as further described in the Specifications;

Examples of Bulk Licensed Product in a sentence

  • With the exception of the supplies of Bulk Licensed Product to be supplied by Schering to Licensee pursuant to Section 6.2, Licensee will be responsible for the Manufacture of Licensed Product for Development and Commercialization of Licensed Product by Licensee, its Affiliates, and its sublicensees in the Field in the Territory.

  • Promptly following the Effective Date of this Agreement, Schering shall transfer to Licensee free of charge (except reasonable costs of transfer as set forth below), in a mutually agreed manner, quantities of Bulk Licensed Product and related documentation (eg, batch records, process and release testing results, protocols, stability data and location of stability specimens) that are reasonably sufficient for Licensee to complete the Proof of Concept Trial and as are further described in Schedule 6.2.

  • In the event of any non-conformity under this Section 2.4.1, Medeva shall have no obligation to pay any amount to TGC greater than the amount corresponding to the lesser of either the quantity of Bulk Licensed Product ordered, or the quantity of Bulk Licensed Product actually received.

  • Such Transfer Price will thereafter, beginning October 1 or April 1, as the case may be, be applied to Medeva's purchases of Bulk Licensed Product from TGC for the ensuing six-month period.

  • The proceeds of the Loan shall be used by Borrower to finance the design, engineering, and construction of a manufacturing facility (the "Manufacturing Facility") for the production of Bulk Licensed Product to supply Phase III clinical trials and commercial sales (to the extent provided in the License and Collaboration Agreement and the Supply Agreement) and to finance the acquisition of furniture, fixtures, and equipment for such facility.

  • If any process event occurs during the manufacturing of any batch or part batch of Bulk Licensed Product (or Licensed Product manufactured by TGC for use by TGC in clinical trials), which event is likely materially to affect the safety, efficacy or regulatory status of such Bulk Licensed Product (or such Licensed Product), then TGC shall notify Medeva as soon as reasonably possible.

  • For example, should wetlands restoration be an appropriate mechanism for offsetting the adverse impact caused by a cooling water intake structure, the permittee could purchase credits from an existing wetlands mitigation bank established in accordance with the Federal Guidance for the Establishment, Use and Operation of Mitigation Banks (50 FR 58605; November 28, 1995).

  • In such case, Medeva shall pay for the quantity actually received in accordance with the provisions of Section 2.3. In the case of any non-conformity which results from delivery of more Bulk Licensed Product than ordered, Medeva may elect either to (i) return to TGC, at TGC's expense, any Bulk Licensed Product in excess of the quantity of Bulk Licensed Product ordered, or (ii) accept any Bulk Licensed Product in excess of the quantity ordered as against future orders of Bulk Licensed Product.

  • Transfer Price shall apply, in the Joint Territory, to Licensed Products in finished, packaged form and, in the Exclusive Territory, to finished dosage form in primary packaging to the specifications provided by Sanofi-Synthelabo to meet the then current requirements of the EMEA (the "Bulk Licensed Product"); for purposes of clarification, finished dosage form in primary packaging may be exemplified by finished dose tablets in drums or finished liquid injectate in vials on pallets.

  • In order to satisfy the anticipated demand for clinical quantities of Bulk Licensed Product (and initial commercial quantities of Bulk Licensed Product, as further described in Section 3.2 below), TGC's present facilities require modification and/or expansion to provide a GMP manufacturing facility suitable for production of Bulk Licensed Product to be used in the manufacture of Licensed Products.


More Definitions of Bulk Licensed Product

Bulk Licensed Product means the Licensed Product in final dosage form using Xxxxxx Xxxxx'x formulation or any Cypress Formulation or any Forest Formulation.
Bulk Licensed Product means Licensed Product in final dosage form or any Forest Formulation, as defined in the Letter Agreement.

Related to Bulk Licensed Product

  • 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.

  • 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.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

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

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

  • Licensed Services means all functions performed by the Licensed System.

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

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

  • Licensed Territory means worldwide.

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

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

  • 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.

  • Licensed Field means all fields of use.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Hemp products means all products made from industrial hemp,

  • 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.

  • 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.

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

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

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Licensed Compound means [***].

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

  • End product means those articles, materials, and supplies to be acquired under the contract for public use.

  • Licensed Service means a service provided using Licensed Products or Licensed Methods, including, without limitation, any such service provided in the form of contract research or other research performed by Licensee on behalf of a third party.

  • Third Party Product means a product (whether hardware, software or services) supplied to you by a third party;