Examples of Development Transition Date in a sentence
AstraZeneca shall and hereby does assume all regulatory responsibilities in connection with Lead Compounds and Products in the Product Field after the Development Transition Date for such Collaboration Target, including all subsequent IND submissions in countries outside the country of the Initial Major Market IND Approval.
On a Collaboration Target-by-Collaboration Target basis, prior to the Development Transition Date for a Lead Compound that targets or mimics, as applicable, such Collaboration Target, Regulus will have the first right, subject to consultation and discussion at the Intellectual Property Sub-committee, but not the obligation, to prepare, file, prosecute and maintain Regulus Product Specific Patents and Joint Product Specific Patents, at Regulus’ sole expense and by counsel of its own choice.
Following the Development Transition Date with respect to each Lead Compound, AstraZeneca will use Commercially Reasonable Efforts to develop, register and commercialize at least one Lead Compound or Product for each Collaboration Target in the Product Field in each of (a) the U.S., (b) any two of the UK, Spain, Germany and France and (c) Japan, in each case in accordance with the terms of this Agreement.
For clarity, following the Development Transition Date with respect to a Collaboration Target, AstraZeneca shall own all INDs, NDAs, XXXx and other regulatory filings and Approvals for such Lead Compound and Products, subject to Regulus’ reversion rights under Article 10.
To the extent that, at the time of the Development Transition Date with respect to a Collaboration Target, any INDs for such Lead Compound in the Product Field are in Regulus’ name, Regulus shall promptly transfer ownership of and responsibility for such IND to AstraZeneca, at AstraZeneca’s expense.
Regulus is responsible for such research and development activities in the R&D Plan (including its funding) up to the Development Transition Date for each Collaboration Target, except as may otherwise be agreed by the Parties as described in this Section.
The Research Program will be carried out in accordance with a written research and development plan that sets forth all research and development activities of the Parties with respect to each Collaboration Target through the Development Transition Date with respect to such Collaboration Target and, prior to designation of the Oncology Target in accordance with Section 3.3, all research activities with respect to Target Pool microRNAs for the purpose of identifying the Oncology Target (the “R&D Plan”).
After the Development Transition Date for any Lead Compound or Product, AstraZeneca will provide an annual report to Regulus summarizing AstraZeneca’s main activities over the past year with respect to the identified Lead Compound or Product and an appropriate number of representatives from each Party will meet at least once every year to review development activities.
A Member is not precluded from attending the meeting in person after lodging the instrument of appointing the proxy, however, such attendance shall automatically revoke the authority granted to that Member’s proxy.
MAXIMUS shall retain responsibility for (1) all operations that comprise the Technology Development Services prior to the Technology Development Transition Date, including, without limitation, the performance of the Technology Development Transition, (2) the development, support, and maintenance of the MAXe software for Enrollment Broker and CHIP, and (3) all break/fix maintenance obligations and related activities for the MAXe software for periods after March 31, 2007.