Examples of Optioned Program in a sentence
Upon each notice of receipt of any such subsequent Antitrust Approval for such Optioned Program, there shall occur an additional Option Exercise Closing for such Optioned Program with respect to the applicable jurisdictions.
As between the Parties, Adimab shall have the sole right, at its sole expense and in its sole discretion, to prepare, file, prosecute, enforce and maintain (including conducting or participating in interferences and oppositions) all Patents directed to Adimab Program Inventions but not falling within the Optioned Program Antibody Patents or the Adimab Platform Technology Improvements (which, to avoid doubt, are both addressed above).
With respect to each Optioned Program, […***…] shall have the right, but not the obligation, to be responsible for establishing (if applicable), holding and maintaining the global safety database for the applicable Optioned Products.
If Gilead exercises such termination right for any country (but not all countries) in the Gilead Territory, then this Agreement shall remain in effect with respect to all other countries in the Gilead Territory and such country with respect to which Gilead exercised such termination right shall become a country in the Galapagos Territory with respect to the applicable Galapagos Program or Optioned Program, as the case may be.
With respect to each Optioned Program, as promptly as reasonably practicable following the Initial Option Closing, Galapagos shall make available to Gilead copies of all records with respect to such Optioned Program maintained by Galapagos pursuant to Section 2.6(b).
For each Optioned Program, each Party shall conduct the activities assigned to it under the applicable R&D Plan and Budget (such activities, collectively, the “Optioned Program R&D Activities”) and use Commercially Reasonable Efforts to achieve the timelines set forth therein.
Subject to the preceding sentence and Section 7.4(b), for each Optioned Program, unless otherwise agreed by the Parties in writing, each Party shall solely own all Regulatory Materials and Regulatory Approvals for any Optioned Product in its Respective Territory.
The Parties will further work together and reasonably take into account the internal and external reporting requirements and timelines of the other Party (i) when preparing reports pursuant to this ARTICLE IX to the other Party, (ii) when aligning the respective R&D Plan and Budget, Global Commercialization Plan and Budget and Global Manufacturing Plan and Budget for each Optioned Program and Third Party License Payments and (iii) during any other planning-related exercise.
Subject to ARTICLE VII, for each Optioned Program, unless otherwise agreed by the Parties in writing, following the Regulatory Transition Date, each Party shall be solely responsible for all regulatory matters (including applications for Regulatory Approval and communications with Regulatory Authorities) and the conduct of all Clinical Trials in its Respective Territory.
Each Party shall and shall cause its Affiliates to maintain complete and accurate records (in the form of technical notebooks or electronic files where appropriate) of all work conducted by it or on its behalf that constitute Significant Pre-Program Activities or that relate to any Galapagos Program or Optioned Program, and all Information resulting from such work.