Notice Under Biologics Price Competition and Innovation Act Sample Clauses

Notice Under Biologics Price Competition and Innovation Act. (a) Each Party shall [ * ] give written notice to the other Party of any BLA for a Biosimilar Product of which they become aware filed pursuant to 21 U.S. CFR § 351(k) (or any amendment or successor statute thereto) or corresponding Applicable Laws in other countries anywhere in the world (each a “Biosimilar Application”) referencing the RC48 Licensed Product or Opt-In Product or claiming that any Licensed Product Patent Covering any RC48 Licensed Product or Opt-In Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale of a product by a Third Party, in which case the remainder of this Section 13.10 shall apply. Regardless of the Party that is the “reference product sponsor”, as defined in 42 U.S.C. § 262(l)(1)(A), for purposes of such Biosimilar Application: (i) For Biosimilar Actions [ * ] (the “Controlling Party”) [ * ] (the “Non-Controlling Party”), [ * ]. The Controlling Party and the Non-Controlling Party shall discuss and agree in good faith upon an appropriate strategy with respect to such Biosimilar Application and any actions taken with respect to such Biosimilar Action shall be consistent with such strategy (as may be revised from time to time by prior written agreement of the Parties hereunder). (ii) The Controlling Party shall [ * ]. Notwithstanding the foregoing, if the Controlling Party is not permitted, pursuant to Applicable Law[ * ] then [ * ] at the reasonable direction of the Controlling Party. (iii) Subject to the then-current strategy [ * ] under clause (i) above, the Controlling Party shall have the right to [ * ]. If the Non-Controlling Party is required pursuant to Applicable Law to execute any of these tasks it shall do so in accordance with the then-current strategy agreed upon between the Parties under clause (i) above and in coordination with the Controlling Party, subject to Section 13.3(d). The Controlling Party shall have the right to [ * ]. (iv) The Controlling Party shall have the right, subject to the then-current strategy agreed upon between the Parties under clause (i) above, to [ * ]. If the Non-Controlling Party is required by Applicable Law to execute any of these tasks, it shall do so in accordance with the Controlling Party’s reasonable instructions, subject to the then-current strategy agreed upon between the Parties under clause (i) above subject to Section 13.3(d). (v) The Non-Controlling Party shall cooperat...
Sample 1
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Notice Under Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in Section 13.3, each Party shall immediately give written notice to the other Party of any BLA for a Biosimilar of which they become aware filed pursuant to 21 U.S. CFR § 351(k) (or any amendment or successor statute thereto) or corresponding Applicable Laws in other countries anywhere in the world (each a “Biosimilar Action”) referencing a Licensed Product or claiming that any Program Specific Patent, Joint Collaboration Patent, or Sutro Patent Covering any Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale of a product by a Third Party. Promptly after a Party receives notice under this Section 13.8, the Parties shall meet and decide upon a strategy and actions for responding to such Biosimilar Action, provided that Astellas shall have the first right (but not the obligation) to control any such response, at its sole expense subject to Section 13.3(e).
Sample 1
Notice Under Biologics Price Competition and Innovation Act. Each Party shall immediately give written notice to the other Party of any BLA for a Competing Product of which they become aware filed pursuant to 21 U.S. CFR § 351(k) (or any amendment or successor statute thereto) or corresponding Applicable Laws in other countries anywhere in the world (each a “Biosimilar Action”) referencing the Licensed Product claiming that any Product Specific Patents Covering Licensed Compound or Licensed Product are invalid or unenforceable, or that infringement will not arise from the Manufacture, use or sale of any product by a Third Party. Promptly after a Party receives notice under this Section 8.1, the Parties shall meet and decide upon a strategy and actions for responding to such Biosimilar Action, provided that Ipsen shall have the first right (but not the obligation) to control any such response, subject to Section 8.5 as if such Biosimilar Action were a Third Party Infringement.
Sample 1

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