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.