Examples of Bulk Licensed Product in a sentence
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.
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.
All such records shall be maintained for such period as may be required by Applicable Laws; provided, however, that all records relating to the manufacture, stability -------- ------- and quality control of each batch, or part batch, of Bulk Licensed Product shall be retained until the Parties agree to dispose of such records.
It is anticipated that such forecast and delivery schedule will require multiple shipments of Bulk Licensed Product.
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 Comhairle believes that it is essential that temporary teachers are treated in the same way as permanent staff and given access to appropriate induction, training and support.
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.
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.
TGC and Medeva intend that TGC will manufacture Bulk Licensed Product at TGC's facilities in Seattle, Washington, United States of America, and pursuant to Section 2.1 supply such Bulk Licensed Products to Medeva.
TGC agrees to report to Medeva, on an annual basis, any atypical process events that are unlikely materially to affect the safety, efficacy or regulatory status of the Bulk Licensed Product (or Licensed Product manufactured by TGC for use by TGC in clinical trials).