Examples of Joint Development Territory in a sentence
At any time prior to the First Commercial Sale in the Joint Development Territory of the Product to which Declined Activities relate, Ambit may at its sole discretion reverse its decision not to fund its share of the Development Costs with respect to a Declined Activity and shall promptly notify Astellas in writing of such decision.
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.
Astellas shall keep Ambit reasonably informed about the status of the activities performed with respect to Astellas’s development and commercialization of Products as provided in Section 2.8.1 and 2.8.2 above, including of the status of Regulatory Approvals for Products outside the Joint Development Territory.
If this Agreement is terminated with respect to any or all Products with respect to one or more Terminated Country(ies) in the Joint Development Territory, but not in its entirety, such Terminated Country(ies) shall be deemed to be excluded from the Joint Development Territory with respect to the applicable Product(s) from and after the effective date of such termination event.
Each Party shall promptly provide the other Party with copies of all material written or electronic communications received by it or its Affiliates from, or forwarded or submitted by it or its Affiliates to, the Regulatory Authorities, in the case of Astellas, solely within the Joint Development Territory, with respect to any Product.
Astellas shall use Commercially Reasonable Efforts to develop each Product that is the subject of a Development Program in the Joint Development Territory through Regulatory Approvals in the countries outside the Joint Development Territory.
Starting from the date of the First Commercial Sale in any country in the Joint Development Territory of a Product to which Declined Development Activities relate, […***…], Astellas shall reduce the total amount due to Ambit hereunder with respect to sales of such Product during the applicable Calendar Year (whether in the form of Ambit’s portion of the U.S. Profit/Loss or royalty payments), by […***…].
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.
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.