Examples of Ipsen Territory in a sentence
Product have all necessary licenses to produce the Product for distribution in Ipsen Territory as mutually agreed.
Such sublicense rights are limited to use of any portion of the Combined Therapy Study Data and Right of Cross-Reference reasonably needed to support regulatory filing and approval of a Combined Therapy, or if required by the relevant Regulatory Authority, in the Ipsen Territory in accordance with and under the Ipsen-Exelixis Agreement (which right shall survive any expiration or termination of this Supplement and the Agreement).
In the event of occurrence during the Additional Phase III Study of GTx’s bankruptcy or a petition against GTx under any bankruptcy, insolvency or similar laws not being dismissed within the applicable period of time, Ipsen shall have the right to elect to conduct or continue the development of the Additional Phase III Study for purposes of, but not limited to, obtaining and maintaining Regulatory Approvals in the ADT Indication within the Ipsen Territory.
Such sublicense rights are limited to use of any portion of the Combined Therapy Study Data and Right of Reference reasonably needed to support regulatory filing and approval of a Combined Therapy, or if required by relevant Regulatory Authority, in the Ipsen Territory in accordance with and under the Ipsen-Exelixis Agreement (which right shall survive any expiration or termination of this Supplement and the Agreement).
The Parties also agree that notwithstanding Section 8.3 above, with respect to filings in the Ipsen Territory, BMS shall provide Ipsen direct access to and Ipsen will provide BMS direct access to all reasonably requested Regulatory Documentation and other documents under each of BMS’, Xxxxx’x and their respective Affiliates’ control that may be necessary or useful for Xxxxx’x or BMS’ preparation of the Regulatory Documentation in the Ipsen Territory.
Quality Systems 5.1 Quality Responsibilities 5.2 Personnel and Management Responsibilities 5.3 Document Retention 5.4 Drug Substance Production 5.5 Drug Product Production 5.6 Release of Product - Ipsen Territory 5.7 Post Release Issues and Product Complaints 5.8 Product Recall and Returns 5.9 Change Control 5.10 Annual Product Quality Reviews 6.
Outside of the United States and more specifically in the Ipsen Territory, the Parties hereby agree that regulatory submission strategy discussions shall occur through the JCS-WG or at ad hoc meetings as may be agreed by the Parties and Ipsen.
For the sake of clarity, Ipsen shall have, and GTx agrees to grant, pursuant to Article 5 of the License Agreement: (i) a non-exclusive royalty-free license to develop the Licensed Product for any Indication under the GTx Know-how and GTx Patent as well as (ii) an exclusive, royalty-bearing license to conduct Commercialization Activities, including the right to sublicense, within the Ipsen Territory for any Indication under the GTx Patent, GTx Know-how and the Licensed Trademark.
For the first calendar year as from the first Launch Date of the toremifene 80mg Licensed Product in the Ipsen Territory for the ADT Indication, Ipsen shall pay, on a country-by-country basis, a Royalty Payment equal to 12% of Net Sales.
In work by Staat (2004),equating the applied M = 2PR(R + a 2) and limit [MStaat ]= σu a2 4 moments, is obtained thatΔP σu = a2 4R1 (2R1 + a).