Examples of Development Territory in a sentence
The Development Programs shall cover the research and clinical development activities intended to generate the data to be used in seeking, obtaining, maintaining and expanding Regulatory Approvals for Products in the Joint Development Territory or for supporting the marketing and selling of Products in the Joint Development Territory, and such activities shall be determined and overseen by the JSC, under the decision-making provisions of Section 2.1.4 below.
All other sublicenses to be granted by Astellas or any Astellas Affiliate in the Joint Development Territory prior to […***…] will require prior written approval from Ambit, which shall not be unreasonably withheld or delayed, provided that in the event such sublicense is to all of Astellas’s rights in the U.S. or the Joint Development Territory to a Person who is not an Astellas Affiliate such approval shall be at Ambit’s sole discretion.
Astellas shall have sole responsibility for planning, coordinating, monitoring, and regulating all aspects of the research and development of Licensed Compounds and Products for the benefit of countries other than those in the Joint Development Territory; provided that the JSC shall review such development activities and coordinate to the extent practicable the Development Plan activities applicable to such Product.
In the event that Astellas retains responsibility for preparing any Regulatory Materials, Astellas shall (a) provide Ambit with an opportunity to review and comment upon any Material Regulatory Submissions in the Joint Development Territory, in each case a reasonable period prior to the anticipated date of such submissions and (b) reasonably consider Ambit’s comments with respect to such submissions or applications in good faith.
All other research, clinical development and regulatory activities for Products that are intended to generate data for use in seeking, obtaining, maintaining and expanding Regulatory Approvals outside the Joint Development Territory shall be discussed and reviewed at a strategic level by the JSC, but Astellas shall have the final decision-making authority at the JSC level over all aspects of such activities as provided in Section 2.1.4 below.