Transition of Responsibilities. After Amgen's exercise of the Option and prior to the Transition Date, ViaCell will transfer to Amgen the IND and all other Regulatory Filings for the Collaboration Product for which Amgen exercised its Option. ViaCell shall also deliver to Amgen a complete copy of the IND and any other Regulatory Filings for the Collaboration Product for which Amgen has exercised its Option and any related correspondence with the FDA and any other Regulatory Authority relating thereto, as well as all related Information and Materials (including but not limited to data and results of ▇▇▇▇▇ ▇, ▇▇▇▇▇ 2 and/or Phase 3 clinical trials, to the extent applicable). On and after the Transition Date for a Collaboration Product, ViaCell will provide all assistance and execute all documents reasonably requested to facilitate the transition of the Development responsibilities, as described in Article III, and the responsibilities of the Commercial Lead, as described in Article VI, for that Collaboration Product to Amgen. For the avoidance of doubt, the exercise of the Option will not affect the rights and responsibilities of the Parties with respect to Cell Therapy Products and/or indications for which the Option Period has not expired. [**].
Appears in 3 contracts
Sources: Collaboration Agreement (Viacell Inc), Collaboration Agreement (Viacell Inc), Collaboration Agreement (Viacell Inc)