Astellas Territory definition
Examples of Astellas Territory in a sentence
Cytokinetics shall have the right, but not the obligation, to conduct additional development to support country-specific Regulatory Approvals for the tirasemtiv Product in ALS in the tirasemtiv Astellas Territory, in reasonable consultation with Astellas.
For clarity, each Party shall have the sole right, at its discretion, to engage in any early access program and/or named patient programs in the Cytokinetics Territory or Astellas Territory, as applicable, at its own cost, and such programs shall not require the other Party’s approval and/or input and shall not be part of the Development Plan or Commercialization Plan or subject to the oversight of any Committee.
Astellas shall be primarily responsible for and shall lead additional Development works to support country specific Regulatory Approval of the Product in the Astellas Territory (the “Astellas Development Activities”).
Subject to the other terms of this Section 9.4 during the Royalty Term, Astellas shall make quarterly non-refundable, non-creditable royalty payments to Cytokinetics on the Net Sales of the Product sold in Astellas Territory at the applicable royalty rate set forth below (unless the Parties agree on an alternative share of commercial returns for specified countries (e.g., transfer payment plus margin)).
In case Astellas desires to change the specification or manufacturing method of the Product for the use of its Development or Commercialization of the Product in Astellas Territory, JMC discuss the allocation of activities necessary for the CMC activities necessary for the change.
Astellas shall be responsible for packaging and labelling of the Product for the use for its Development and Commercialization of the Product in Astellas Territory.
Astellas shall be responsible for and shall lead all regulatory activities necessary to obtain and maintain Regulatory Approval of Tirasemtiv and Product in the Astellas Territory, at Astellas’ own cost and expense.
Each Party may attend conferences or congresses in the other Party’s portion of the Territory, at its option; provided, however, that Astellas shall be responsible for leading the presence of the Parties at any conference or congress (whether international or regional) in the Astellas Territory, and Frequency shall be responsible for leading the presence of the Parties at any conference or congress (whether international or regional) in the Frequency Territory.
Upon the first [ * ] in the Astellas Territory for the [ * ]; provided, that in the event Astellas chooses the Bridging Strategy, such payment shall be increased by an additional U.S. $[ * ] for a total of U.S. $[ * ].
If Astellas so exercises such Option in accordance with this Section 2.5(d)(i), then upon Cytokinetics’ receipt of both such written notification and payment, Astellas’ exercise of the Option shall be deemed effective and the tirasemtiv Agreement shall become effective automatically and [*] shall be included and deemed as the tirasemtiv Astellas Territory.