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.