Non-Action or Claim. As of the Effective Date, there are no pending or threatened in writing, or to Knowledge of Eisai, threatened adverse actions, suits, claims, or formal governmental investigations by or against Eisai or any of its Affiliates in or before any court, Regulatory Authority or other governmental authority in the Territory with respect to Eisai’s marketing, promotion or sale of pharmaceutical products in the Territory that would materially negatively affect Eisai’s ability to perform its obligations under this Agreement or the Supply Agreement.
Non-Action or Claim. As of the Effective Date, there are no pending or threatened in writing, or to Knowledge of Arena, threatened adverse actions, suits, claims, or formal governmental investigations by or against Arena or any of its Affiliates in or before any court, Regulatory Authority or other governmental authority in the Territory with respect to the Compound or the Initial Product, including in connection with the conduct of any clinical trials or manufacturing activities with respect thereto. As of the Effective Date, there are no material unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations or awards (whether rendered by a court, an administrative agency or by an arbitrator) against Arena (or any of its Affiliates) in the Territory with respect to the Compound or the Initial Product.
Non-Action or Claim. To the best of its knowledge, there are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations (i) involving the Staccato Device or Product, including in connection with the conduct of any clinical trials or manufacturing activities by Alexza, its Affiliates or licensees, or (ii) questioning the validity of this Agreement or any action taken by Alexza in connection with the execution of or activities under this Agreement, in each case, by or against Alexza or any of its Affiliates or licensees in or before any court, FDA or other governmental authority. There are no material unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations, settlements or awards (whether rendered by a court, an administrative agency or an arbitrator) against Alexza with respect to any Alexza Technology, the Drug, the Staccato Device or the Product.
Non-Action or Claim to AcelRx’s Best Knowledge, there are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations (i) involving the Device or the Licensed Product, including in connection with the conduct of any clinical trials or manufacturing activities, or (ii) questioning the validity of this Agreement or any action taken by AcelRx in connection with the execution of this Agreement, in each case, by or against AcelRx or any of its Affiliates in or before any court, Regulatory Authority or other governmental authority. There are no material unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations or awards (whether rendered by a court, an administrative agency or an arbitrator) against AcelRx with respect to any AcelRx Technology, the Device or the Licensed Product.
Non-Action or Claim. As of the Effective Date, there are no actual, pending, or alleged or threatened in writing, adverse actions, suits, claims, interferences or formal governmental investigations by or against ACADIA or any of its Affiliates in or before any court, Regulatory Authority or other governmental authority involving any ACADIA […***…] Patents, ACADIA Technology, Pimavanserin or any Product, including without limitation, in connection with the conduct of any clinical trials or manufacturing activities. As of the Effective Date, there are no material unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations or awards (whether rendered by a court, an administrative agency or by an arbitrator) against ACADIA with respect to any ACADIA […***…] Patents, ACADIA Technology, Pimavanserin or any Product.
Non-Action or Claim. To Aquestive’s knowledge, as of the Effective Date, there are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations (i) involving the Product, including in connection with the conduct of any clinical trials or manufacturing activities by Aquestive or its Affiliates, or (ii) questioning the validity of this Agreement or any action taken by Aquestive in connection with the execution of or activities under this Agreement, in each case, by or against Aquestive or any of its Affiliates in or before any court, FDA or other Governmental Entity. As of the Effective
Non-Action or Claim. As of the Effective Date, there are no pending, or threatened in writing, adverse actions, suits, claims, or formal governmental investigations by or against Arena or any of its Affiliates in or before any court, Regulatory Authority or other governmental authority in the Territory with respect to the Compound or the Initial Product, including in connection with the conduct of any clinical trials or manufacturing activities with respect thereto. As of the Effective Date, there are no material unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations or awards (whether rendered by a court, an administrative agency or by an arbitrator) against Arena (or any of its Affiliates) in the Territory with respect to the Compound or the Initial Product.
Non-Action or Claim. As of the Effective Date, there are no actual or pending, and to the best of OptiNose’s and its Affiliates’ knowledge, no alleged or threatened, adverse actions, suits, claims, interferences, post-grant proceedings, or formal governmental investigations, or settlements or judgments, involving the Product and/or Device, and/or the OptiNose IP by or against OptiNose or any of its Affiliates in or before any Governmental Authority. In particular, to the best of OptiNose’s and its Affiliates’ knowledge, there is no pending or threatened product liability or patent action involving the use or administration of the Product and/or Device;
Non-Action or Claim. As of the Effective Date, to Chroma’s Best Knowledge, there are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations involving the Product and/or the Chroma Technology by or against Chroma or any of its Affiliates in or before any court, governmental or Regulatory Authority. In particular, as of the Effective Date, to its Best Knowledge, there is no pending or threatened product liability action involving the Product. As of the Effective Date, there are no claims, judgments or settlements against or owed by Chroma relating to the Chroma Technology or the Product.
Non-Action or Claim. There are no pending, and to Trellis’s knowledge no threatened, actions, suits or proceedings against Trellis involving the Trellis Technology. To Trellis’s actual knowledge, with no duty of inquiry, there are no activities by Third Parties that would constitute infringement or misappropriation of the Trellis Technology as it relates to Trellis Antibodies or Products (in the case of pending claims, evaluating them as if issued as of the Effective Date).
