Expansion Scope definition
Examples of Expansion Scope in a sentence
GSK will provide to Amgen a copy of all development documents used in the Expansion Scope; provided, that GSK will not be required to provide such development documents in advance of their use if they are consistent with the materials provided by Amgen to GSK under Section 5.1.4.1 (Development).
If Amgen ceases to use any particular promotional material outside the Expansion Scope because it believes such material may no longer be accurate or appropriate for use, GSK will cease use of any such corresponding Promotional Material for the Expansion Scope (or the Parties will agree upon appropriate modifications to the Promotional Material) upon notice from Amgen.
If requested by Amgen prior to submission of an application for Regulatory Approval to market Ivory in a country in the Expansion Scope, GSK will promote Ivory in each indication in such country within the Expansion Scope only under the same Product Trademark utilized by Amgen for such indication outside the Expansion Territory, unless otherwise agreed by the Parties.
Such costs will include only those costs that are incurred by Amgen or its Affiliates in connection with discrete activities that are incremental to Amgen’s activities for its own purposes and are requested by GSK to support GSK’s efforts to develop, obtain Regulatory Approval of or commercialize Ivory in the Expansion Scope (such as analytical technology transfer to Governmental Authorities).
Each Party will promptly notify the other Party of any violation of Applicable Law by its personnel with respect to the conduct of activities in the Expansion Scope under this Agreement.
If requested, GSK will prepare a detailed written plan for such EDC meeting (including detailed timelines and a date by which it expects to obtain Regulatory Approval) of the activities that GSK has undertaken, is undertaking and will undertake to obtain Regulatory Approval for Ivory in the Expansion Scope as soon as reasonably practicable in the applicable country.
The appropriate attribution of such costs to the Expansion Scope may be determined based upon percent of effort, resource utilization or other reasonable measure.
Each Party will fully and promptly inform the EOC with respect to its activities in the Expansion Scope undertaken pursuant to this Agreement as reasonably requested by any member thereof.
For clarity, GSK will have no right to and will not utilize any Confidential Information of Amgen for activities outside the Expansion Scope or for activities related to products other than Ivory.
The EDC will discuss what Regulatory Filings, if any, related to Ivory outside the Expansion Scope would be useful for GSK to use with respect to the registration of Ivory in the Expansion Scope.