Option Data definition
Examples of Option Data in a sentence
The initial Split Territory Global Development Plan for each Split Territory Agreement Product shall be included in the Option Data Package for such Split Territory Agreement Product provided by Voyager to Genzyme under Section 3.2.1 (Option Notice; Option Data Package).
In addition, Voyager shall be required to promptly provide supplemental update(s) to Genzyme if new material information becomes available to Voyager that would have been included in the Option Data Package had such information been available to Voyager at the time the Option Notice was delivered (including any Safety Concern or Serious Adverse Event information).
Unless the DAC elects to utilize the Genzyme PD Technology in accordance with Section 4.5 (Use of Genzyme PD Technology) or unless otherwise agreed by Genzyme, the initial Split Territory Global Development Plan for the PD Agreement Product will contain all of the Development activities set forth in the Collaboration R&D Plan for the PD Collaboration Program attached hereto as Schedule 4.3.1-2 that are not yet completed at the time of the delivery of the Option Data Package.
On an Option-by-Option basis, as promptly as practicable following Voyager’s delivery of an Option Data Package to Genzyme, but not later than the applicable Option Exercise Date with respect to such Option, Genzyme shall determine whether any filing or notification is necessary or advisable under any applicable Antitrust Law if Genzyme were to exercise the respective Option pursuant to this Agreement.
The DAC shall review and approve such initial Split Territory Global Development Plan prior to its inclusion in such Option Data Package.
Following delivery of the Option Data Package, if Amgen requests that Xencor provide information known to Xencor relating to the accuracy of any representation or warranty made by Xencor in Section 10.2 as if made on the date of such request, then to the extent such information has not previously been disclosed to Amgen, Xencor shall provide such information to Amgen within 30 days after such request.
Notwithstanding the foregoing, in the event of a dispute as to whether all Core Collaboration Period Development Activities or the Option Data Package have been completed or delivered, this Agreement shall not terminate under this Section 9.2, and the Option Period shall be tolled until such dispute has been resolved in accordance with Article 12.
Promptly following completion of the corresponding activities under the Development Plan for the Pegaspargase Product, Pfenex shall provide Jazz with Option Data Package 1 and, if Jazz has not previously delivered to Pfenex an Option Exercise Notice or if Jazz delivered an Option Exercise Notice but the Parties were unable to negotiate and enter into an Option Exercise Agreement pursuant to Section 2.4(d), Option Data Package 2.
In connection with the foregoing, unless Amgen exercises the Option prior to the completion of the Core Collaboration Period Development Activities, as promptly as possible following the completion of the Core Collaboration Period Development Activities, Xencor shall prepare and deliver to Amgen the Option Data Package.
Notwithstanding the foregoing, Voyager shall not deliver an Option Notice to Genzyme prior to Human POP Study Completion for the Collaboration Product and unless and until all of the activities necessary to generate the information set forth on Schedule 1.173 (Option Data Package) have been completed.