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 Licensed Product in final dosage form or any Forest Formulation, as defined in the Letter Agreement.

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.

  • Xxxxxx Xxxxx further grants Cypress a license to use Xxxxxx Xxxxx Know-How and Xxxxxx Xxxxx Patents, to the extent necessary to formulate or have the API formulated into Bulk Licensed Product and package Bulk Licensed Product into Finished Licensed Product, solely for sale of Licensed Product in the Licensed Territory.

  • Effective December 31, 2008, Executive hereby resigns as an employee, officer, director and from all other positions he holds with Company and its subsidiaries, Executive’s employment is hereby terminated as of December 31, 2008, and the Company accepts such resignation.

  • TGC shall provide Medeva with a reasonable description of each such visit or inspection promptly (but in no event later than five (5) calendar days) thereafter, and with copies of any letters, reports or other documents (including 483's) issued by any such authorities that relate to the Bulk Licensed Product, Licensed Product, or such facilities, processes or procedures.

  • Medeva and TGC shall consult with each other as to the disposition of all affected batches or part batches of such Bulk Licensed Product (or such Licensed Product).

  • Cephalon may engage third party manufacturers to produce the active pharmaceutical ingredient of Bulk Licensed Product or Bulk Licensed Product itself with the prior written consent of Sanofi-Synthelabo, which consent shall not be unreasonably withheld.

  • No Bulk Licensed Product may be reworked unless the rework procedure is in conformity with the applicable Regulatory Approval or the other applicable guidelines of the Government Authority in the country where the Licensed Product is being sold, except with the prior written consent of Medeva, which consent may not be unreasonably withheld.

  • TGC shall maintain, and shall cause its Affiliates, Contract Manufacturers, Outside Contractors and other agents to maintain, all records necessary to comply with all Applicable Laws relating to the manufacture, filling, packaging, storage and shipment 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.


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 TGC's CFTR gene therapy product, as further described in the Specifications;

Related to Bulk Licensed Product

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

  • 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.

  • 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.

  • 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 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.

  • 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.

  • 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;